BREA, Calif., July 23,
2020 /PRNewswire/ -- Beckman Coulter today announced that
it has received 510(k) clearance from the U.S. Food & Drug
Administration (FDA) for its PK7400 Automated Microplate
System and the system's reagents have completed FDA approval.
Designed for use in blood donor and plasma centers, as well as
large reference laboratories, the PK7400 Automated Microplate
System offers the industry's highest throughput for a single
analyzer in its class and is now available in countries
across Europe, Canada and the
United States.
According to the AABB (formerly the American Association of
Blood Banks), an estimated 33,000 units of blood are needed each
day to meet patient need. However, the organization also stated,
more than 4,000 blood donation events have been cancelled due to
the COVID-19 pandemic.
"Blood donation is critically important under normal
circumstances, as one donation can save up to three lives, but even
more so now," said Shamiram R.
Feinglass, M.D., MPH, chief medical officer, Beckman
Coulter. "During this challenging time, those that are feeling
well and healthy should continue to make and keep donation
appointments to help ensure life-saving blood is available for
patients that need it most."
"Along with the need for physical donors, blood donation and
plasma centers require tools that enable them to reliably test and
process the samples that are coming in, so they can quickly make
them available for patients," said Kathleen
Orland, vice president and general manager of Beckman
Coulter's Chemistry and Immunoassay business. "Our PK7400 is
designed to optimize workflow, minimize hands-on time and
increase productivity, allowing users to focus their time on
protecting the health and safety of donors, patients and blood
center staff."
The PK7400 Automated Microplate System:
- Offers the industry's highest throughput for a single analyzer
in its class, processing up to 300 samples per hour with a maximum
of 12 tests per sample
- Includes proprietary liquid and ready-to-use reagents
- Provides the end user the ability to test multiple assays in a
single batch without decreasing the throughput
-
- The assay menu includes ABO blood grouping, Rh typing, weak D
testing, Rh-Kell phenotyping, as well as syphilis and CMV
qualitative screening†
"The PK7400 is a user-friendly analyzer with the capacity to
test a large throughput with rapid, accurate results," said
Christie Garza, laboratory
specialist at Gulf Coast Regional Blood Center. "The software is
easy to navigate, and results can be interpreted quickly and
easily."
For details on where to donate blood locally, see AABB's blood
donor center locator. For more information on the PK7400, visit
www.beckmancoulter.com/pk7400.
About Beckman Coulter
Beckman Coulter is committed to
advancing healthcare for every person by applying the power of
science, technology and the passion and creativity of our teams to
enhance the diagnostic laboratory's role in improving healthcare
outcomes. Our diagnostic systems are used in complex biomedical
testing, and are found in hospitals, reference laboratories and
physician office settings around the globe. Beckman Coulter offers
a unique combination of people, processes and solutions designed to
elevate the performance of clinical laboratories and healthcare
networks. We do this by accelerating care with a menu that matters,
bringing the benefit of automation to all, delivering greater
insights through clinical informatics and unlocking hidden value
through performance partnership. An operating company of Danaher
Corporation (NYSE: DHR) since 2011, Beckman Coulter is
headquartered in Brea, Calif., and
has more than 11,000 global associates working diligently to make
the world a healthier place.
† For Investigational Use Only. The performance
characteristics of this product have not been established. Pending
clearance by the United States Food and Drug Administration; not
yet available for in vitro diagnostic use in the US.
© 2020 Beckman Coulter. All rights reserved. Beckman Coulter,
the stylized logo, and the Beckman Coulter product and service
marks mentioned herein are trademarks or registered trademarks of
Beckman Coulter, Inc. in the United
States and other countries.
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SOURCE Beckman Coulter Diagnostics